510(k) K121351 ยท LRC Instrument, Ent Manual Surgical
SINUS DILATION SYSTEM
| Applicant | Entrigue Surgical, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Aug 29, 2012 |
| Received | May 4, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121351
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.